New Jersey-based DermaRite Industries has introduced a voluntary recall of particular person numerous cleaning soap and skincare merchandise resulting from microbial contamination, which has been recognized as Burkholderia cepacia, the corporate mentioned final week.
The bacterium could cause severe and life-threatening infections.
The Meals and Drug Administration (FDA) printed a recall announcement on August 9. Impacted merchandise embody over-the-counter (OTC) antiseptic lotion soaps, exterior analgesics, antimicrobial foam soaps, and antiseptic cleansers.
The next merchandise are included within the recall:
- OTC Healthcare antiseptic lotion cleaning soap DermaKleen
- OTC Exterior Analgesic DermaSarra
- OTC Antimicrobial foam cleaning soap KleenFoam
- OTC Antiseptic cleanser PeriGiene
The FDA recall discover features a listing of impacted merchandise with their lot numbers, expiration dates, reorder numbers, product descriptions, and product labels. The recalled merchandise have been distributed nationwide in the US and Puerto Rico.
You too can discover full-color photos of the impacted product labels on DermaRite’s web site. The corporate says it has not obtained any studies of opposed occasions associated to the recall.
Bacterial an infection might trigger life-threatening sepsis
In line with a “threat assertion” printed by DermaRite, the contaminated merchandise could also be utilized by immunosuppressed people and folks caring for immunosuppressed people.
Burkholderia cepacia could cause severe, life-threatening infections, in accordance with the Facilities for Illness Management and Prevention (CDC).
Whereas wholesome people with minor pores and skin lesions are solely prone to expertise native infections, folks with weakened immune programs are extra in danger.
For immunosuppressed people, the an infection is extra prone to unfold into the bloodstream and will result in life-threatening sepsis. Sepsis could cause in depth irritation all through the physique and trigger tissue injury, organ failure, and loss of life.
Customers ought to destroy impacted merchandise
DermaRite alerted distributors and clients to the voluntary recall by e mail and instructed them to look at their stock and destroy all affected merchandise instantly.
When you have questions in regards to the recall, contact Mary Goldberg by calling 973-569-9000 x104 Monday by Friday, 9:00 am to five:00 pm EST or by emailing voluntary.motion@dermarite.com.
When you have skilled issues associated to utilizing the impacted merchandise, contact a healthcare supplier. Report any opposed reactions skilled because of utilizing these merchandise to the FDA’s MedWatch Adversarial Occasion Reporting program.
You possibly can file a report on-line, obtain a reporting type, or name 1-800-332-1088 to request a reporting type to submit by fax or mail.
